Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

NCT04227873 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-02-18

No results posted yet for this study

Summary

Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids).

Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting.

Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied.

The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.

Conditions

  • Sleep Disturbance
  • Delirium
  • Arthroplasty Complications

Sponsors & Collaborators

  • Kehlet, Henrik, M.D., Ph.D.

    collaborator INDIV
  • Nicolai Bang Foss

    collaborator UNKNOWN
  • Poul Jenum

    collaborator UNKNOWN
  • Anders Troelsen

    collaborator UNKNOWN
  • Kirill Gromov

    collaborator UNKNOWN
  • Mette Grentoft

    collaborator UNKNOWN
  • Henning Piilgaard Hansen

    collaborator UNKNOWN
  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Henrik Kehlet, Dr.med,Phd · Rigshospitalet, Denmark

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227873 on ClinicalTrials.gov